Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For Idiopathic Pulmonary Fibrosis (IPF) cohort:
Minimum age: 40 years
Diagnosis of IPF
Chronic cough (\>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) \>25% of predicted normal at Visit 1
Patients may be either:
* On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
* Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
Patients aged ≥40 years when signing the informed consent
For Progressive Pulmonary Fibrosis (PPF) cohort:
Minimum age: 18 years
Diagnosis of PPF
Chronic cough (\>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
FVC ≥45% of predicted normal at Visit 1
DLCO ≥25% of predicted normal at Visit 1
If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
Patients may be either:
* On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
* Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
You may not be if
Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC \<0.7 at Visit 1
Known reversible airflow obstruction/response to bronchodilators
In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
Current smokers (tobacco use within the 6 months prior to Visit 1)
Clareo Health | A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
